August 5, 2009 – Nile Therapeutics Inc. said this week it dosed its first patient in a phase 2 clinical study of its lead product, CD-NP, for the treatment of acute heart failure.
The single-blind, placebo-controlled study is designed to provide additional information on the safety and tolerability of CD-NP when infused for up to 72 hours in patients with acute heart failure and mild to moderate renal insufficiency. Additional exploratory endpoints will include assessments of CD-NP's ability to relieve symptoms of acute heart failure and its effects on biomarkers of heart failure and renal function. The study is expected to enroll approximately 30 to 40 patients in the United States, Germany and Israel and will examine up to three doses of CD-NP.
"Currently there is a significant unmet need in acute heart failure for treatments that can both relieve symptoms and also preserve or enhance renal function in these patients," said James Young, MD, George and Linda Kaufman chair and professor, Cleveland Clinic, and the principal investigator on the study. "The potential of CD-NP to meet both of these objectives is a compelling scientific story, and is of particular clinical importance for the approximately two-thirds of heart failure patients with pre-existing renal dysfunction."
Previously reported results of a phase 1b study in chronic heart failure patients showed that CD-NP infusion was associated with an improvement in renal function. Previously reported interim results from the first cohort of a Phase 2a study in patients hospitalized for acute heart failure also showed that CD-NP infusion was associated with clinically meaningful improvements in cardiac filling pressures, which are expected to correlate with improvement in symptoms in acute heart failure.
Nile expects to announce interim results of the study later this year, with results from the full study available in 2010.
For more information: www.nilethera.com